A Prediction Model for Monitoring Ribbed Roller Compacted Ribbons

Quyet, Pham V.; Samanta, Asim Kumar; Liew, Celine Valeria; Chan, Lai Wah; Heng, Paul Wan Sia

doi:10.1002/jps.23635

Cited by 11 publications

(7 citation statements)

References 21 publications

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“…Recent publications illustrate the benefits of the Quality by Design approach to process design (Heiman et al, 2015;Souihi et al, 2015Souihi et al, , 2013. In that context, the interest in PAT tools, such as NIR in process monitoring, has been increasing (McAuliffe et al, 2015;Quyet et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

RTD-based material tracking in a fully-continuous dry granulation tableting line

Martinetz

Karttunen

Sacher

et al. 2018

International Journal of Pharmaceutics

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Continuous manufacturing (CM) offers quality and cost-effectiveness benefits over currently dominating batch processing. One challenge that needs to be addressed when implementing CM is traceability of materials through the process, which is needed for the batch/lot definition and control strategy. In this work the residence time distributions (RTD) of single unit operations (blender, roller compactor and tablet press) of a continuous dry granulation tableting line were captured with NIR based methods at selected mass flow rates to create training data. RTD models for continuous operated unit operations and the entire line were developed based on transfer functions. For semi-continuously operated bucket conveyor and pneumatic transport an assumption based the operation frequency was used. For validation of the parametrized process model, a pre-defined API step change and its propagation through the manufacturing line was computed and compared to multi-scale experimental runs conducted with the fully assembled continuous operated manufacturing line. This novel approach showed a very good prediction power at the selected mass flow rates for a complete continuous dry granulation line. Furthermore, it shows and proves the capabilities of process simulation as a tool to support development and control of pharmaceutical manufacturing processes.

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Section: Introductionmentioning

confidence: 99%

RTD-based material tracking in a fully-continuous dry granulation tableting line

Martinetz

Karttunen

Sacher

et al. 2018

International Journal of Pharmaceutics

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“…Most of the recent studies performed by Acevedo et al (35), Crowley et al (36), and McAuliffe et al (37), focused only on monitoring of ribbon density, demonstrating the suitability of NIR spectroscopy for evaluating ribbons of variable quality. The broad applicability of NIR spectroscopy to simultaneously determine CQAs of ribbons, such as drug content, density, tensile strength and Young's modulus of roller-compacted ribbons has also been demonstrated by Gupta et al (38), Samanta et al (39) and Quyet et al (40). Their results demonstrate the possibility of identifying overcompressed or under compressed ribbons or ribbons containing a higher or lower percentage of API in real-time.…”

Section: Application Of Near-infrared Spectroscopy In Monitoring the Roller Compaction Processmentioning

confidence: 89%

“…The research articles listed above demonstrate that NIR can be successfully utilized for monitoring single- (24,28,35) or multi-component (12,36,37) placebo blends. Moreover, studies have also included mixtures containing API (24,(38)(39)(40)(41)(42), offering better insight into potential monitoring of the roller compaction process of real formulation.…”

Section: Application Of Near-infrared Spectroscopy In Monitoring the Roller Compaction Processmentioning

confidence: 99%

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

Vovko

Vrečer

2020

Acta Pharmaceutica

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This article presents an overview of using process analytical technology in monitoring the roller compaction process. In the past two decades, near-infrared spectroscopy, near-infrared spectroscopy coupled with chemical imaging, microwave resonance technology, thermal effusivity and various particle imaging techniques have been used for developing at-, off-, on- and in-line models for predicting critical quality attributes of ribbons and subsequent granules and tablets. The common goal of all these methods is improved process understanding and process control, and thus improved production of high-quality products. This article reviews the work of several researchers in this field, comparing and critically evaluating their achievements.

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“…[20][21][22][23] It offers benefits (in-line, nondestructive, and rapid) over traditional volumetric methods and provides capabilities for realtime monitoring and control of ribbon SF. Other examples include the use of spectral slope calibration approach for monitoring the roller compaction process, 24 ribbon density prediction, 25,26 and to monitor the tablet relaxationphenomenon. 27 An NIR-based method must be developed using samples including most, if not all, the variability to be encountered during its lifecycle.…”

Section: Ribbon Bulk Density Materials True Density ð1þmentioning

confidence: 99%

Understanding the Impact of Chemical Variability and Calibration Algorithms on Prediction of Solid Fraction of Roller Compacted Ribbons Using Near-Infrared (NIR) Spectroscopy

et al. 2016

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The study is aimed at developing a near-infrared (NIR) method for predicting solid fraction (SF) of dry granulated ribbons manufactured with formulation variability. The study investigated the impact of unmodeled chemical variability and regression approaches on method performance. The study utilized an excipient-only formulation system. Calibration compacts were created with chemical and processing variability; followed by collection of NIR spectra. Partial least squares (PLS) and spectral slope algorithms were utilized to model compact SF. Later, the models were deployed to predict SF of test ribbons and compacts containing an API at various concentrations. The risk associated with unmodeled chemical variation manifested itself through generation of new peaks and decreased baseline absorbance in the NIR spectra. The spectral slope was able to better manage this risk, as demonstrated by relatively higher robustness to the increasing load of the active pharmaceutical ingredient (API). The reduced robustness of the PLS approach was attributed to the impact of chemical variability on both spectral baseline and peak absorbance. A prediction error of approximately 5% was observed at 10% drug load using the spectral slope approach. An understanding of the risk associated with unmodeled variability will enable NIR method development as an API sparing technique for low-dose product development.

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A Prediction Model for Monitoring Ribbed Roller Compacted Ribbons

Cited by 11 publications

References 21 publications

RTD-based material tracking in a fully-continuous dry granulation tableting line

RTD-based material tracking in a fully-continuous dry granulation tableting line

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

Understanding the Impact of Chemical Variability and Calibration Algorithms on Prediction of Solid Fraction of Roller Compacted Ribbons Using Near-Infrared (NIR) Spectroscopy

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